Kornimate/medical-research-clean huggingface dataset:
icl and lasik for hyperopic astigmatism

Conditions: Astigmatism; Hyperopia

Summary: this study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. the first step involves implanting a specially designed lens inside the eye (a spherical implantable collamer lens, or icl) to improve vision. later, a laser procedure (lasik) is performed to fine-tune the results for even better clarity.

to assess refractive and visual outcomes of a spherical implantable collamer lens (icl) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (lasik) in the treatment of high compound hyperopic astigmatism. in this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 d hyperopia and ≥2.00 d of astigmatism underwent surgery receiving a spherical implantable collamer lens (icl) followed by a planned adjunctive lasik postoperatively. outcomes measures included postoperative uncorrected (udva) and corrected distance visual acuity (cdva), manifest refraction, spherical (seq) and defocus equivalent (deq), efficacy index, safety index, and astigmatism vector analyses.

Eligibility criteria:
inclusion criteria: * preoperative hyperopic sphere of ≥+3.50 d * astigmatism of ≥+2.00 d * stable refraction for the previous 12 months * age older or equal to 18 years * anterior chamber depth (acd) from corneal endothelium to anterior lens capsule of 3.0 mm or greater exclusion criteria: * age younger than 18 years * patients lost to follow-up * cataract formation * history of glaucoma or retinal detachment * macular degeneration * diabetic retinopathy * history of ocular inflammation * signifcant irregular corneal topography * evidence of inconsistent imaging from dry eyes

Keywords: icl lasik hyperopia astigmatism
comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in hepa-filtered room and non-hepa-filtered room

Conditions: Multiple Myeloma

Summary: the goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in hepa-filtered room and non-hepa-filtered room. the main questions it aims to answer are: * the incidence of febrile neutropenia, infection, and duration of hospital stay * 2-year progression free survival participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record.


Eligibility criteria:
inclusion criteria: * aged 18 - 65 years old * patients with multiple myeloma undergoing treatment with autologous stem cell transplantation and having a hematopoietic cell transplantation-specific comorbidity index (hct-ci) score less than or equal to 2 * patients must provide signed consent to participate in the research if they undergo asct after the study has been approved. * if patients undergo asct before the study approval, retrospective data will be collected. exclusion criteria: * patients with concomitant other types of cancer * patients who refuse to participate in the study.

Keywords: multiple myeloma autologous stem cell transplantation hepa-filtered room non-hepa-filtered room
reset-mg: a study to evaluate the safety and efficacy of caba-201 in participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis (gMG)

Summary: reset-mg: a phase 1/2 open-label study to evaluate the safety and efficacy of caba-201 in participants with generalized myasthenia gravis

myasthenia gravis (mg) is a rare autoimmune disorder characterized by autoantibody responses that cause defective transmission of signals at the neuromuscular junction, resulting in a distinctive pattern of weakness. patients with generalized mg (gmg) typically experience symptoms associated with ocular disease in addition to weakness of many other voluntary muscle groups, including extremity, bulbar, and respiratory muscles. mg is considered a classic example of a b-cell mediated autoimmune disease. currently, there are no curative treatments for mg. this study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, caba-201, that can be given to patients with gmg. a single dose of caba-201 in combination with cyclophosphamide (cy) and fludarabine (flu) will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤70 years of age * diagnosis of mg with generalized muscle weakness meeting criteria as defined by the mgfa class ii, iii , iva, and ivb. * diagnosis of seropositive (autoantibodies achr, musk and/or lrp4) or seronegative mg exclusion criteria: * contraindication to leukapheresis * history of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * active infection requiring medical intervention at screening * current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. * concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * significant lung or cardiac impairment * prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant other protocol-defined inclusion/exclusion criteria may apply.

Keywords: caba-201 autoimmune disease anti-cd19 car-t therapy cellular therapy myasthenia gravis neuromuscular anti-achr anti-lrp4 anti-musk
a randomized phase iii study of adjuvant chemotherapy with or without chemo-radiotherapy in patients with local advanced gastric cancer after d2 resection.

Conditions: Gastric Cancer

Summary: the purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * gastric cancer; * d2 and r0 resection; * pathologically confirmed stage anyt, n+, m0 (ajcc cancer staging); * karnofsky performance score (kps) \>= 70 or eastern cooperative oncology group(ecog) score 0-1; * adequate blood counts: white blood cell count ≥3.5 x 109/l haemoglobin levels ≥100g/l platelet count ≥100 x 109/l creatinine levels ≤1.0× upper normal limit（unl） urea nitrogen levels ≤1.0× upper normal limit（unl） alanine aminotransferase(alt) ≤1.5× upper normal limit（unl） aspartate aminotransferase(ast) ≤1.5× upper normal limit（unl） alkaline phosphatase(alp) ≤1.5× upper normal limit（unl） total bilirubin(tbil) ≤1.5× upper normal limit（unl） * no allergic history of 5-fu or platinum drugs; * no history of chemotherapy or other anti-cancer therapy; * informed consent should be signed. exclusion criteria: * gej adenocarcinoma * concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma) * allergic to fluorouracil or platinum drugs; * concurrent uncontrolled medical condition; * known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract; * severe postoperative complications such as anastomotic leakage, etc.; * symptoms or history of peripheral neuropathy.

Keywords: gastric cancer adjuvant chemo-radiotherapy
effects of osteopathic manipulative therapy on arrhythmias

Conditions: Cardiac Arrhythmia

Summary: the study focuses on patients who have already been diagnosed with an arrhythmia. this is a randomized control trial that will use measurements from the implanted devices to quantify changes in the number of cardiac events experienced. subjects will present to the long island heart rhythm clinic (lihrc) at the new york institute of technology (nyit) academic health care center for their scheduled appointment with dr. cohen. these patients are generally coming in for their electrophysiology cardiology checkup, postsurgical visit, or consultation concerning their cardiac health. once confirmed the patients meet the inclusion criteria, they will be informed about this proposed study and asked if they would like to participate. they will then be consented and randomized according to the randomization procedure outlined below. once enrolled, the patients will complete the study as outlined in the procedures below. they will have a baseline ekg taken, and then proceed to either osteopathic manipulative medicine (omm) treatment or control somatic dysfunction (sd) evaluation. the investigators will then analyze the carelink data, or the web-based management service for the respective device, to quantify the effects the omm or control sd evaluation had on any arrhythmia events. all investigators delivering omm will be neuromuscular medicine/osteopathic manipulative medicine (nmm/omm) board certified attending physicians and trained in the specific techniques that have been associated with arrhythmia sds and treatment modalities to have consistency when treating subjects. subject confidentiality will be maintained throughout the process as delineated in question 5 of the protocol document.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age * subject has an implanted device connected to carelink, merlin, or respective web-based monitoring device, for at least one month * subject has documented diagnosis of a controlled arrhythmia * if subject has been prescribed anticoagulants, the patients has been taking them for at least one month prior to intervention exclusion criteria: * subject planning any surgeries, device updates or changes in the next month * subject's treatment regimen, including any medications, will be changed in next month * subject has contraindications to undergo omt, which include prior spinal surgery, prior spinal fracture, any acute fractures over regions being treated or open wounds, current infection, or any other medical conditions that would prohibit omt * subject is pregnant

Keywords: osteopathic manipulative medicine
a phase 3, randomized, double blind, placebo-controlled, multi-center, withdrawal study of mci-196 in ckd on dialysis with hyperphosphatemia

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Summary: this is a phase iii multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing mci-196 with placebo for 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female, and is \>=18 years old * stable hemodialysis or peritoneal dialysis * subjects has stable phosphate control * subjects on stabilized phosphorus diet * subjects undergoing regular dialysis treatment * female and of child-bearing potential have a negative serum pregnancy test. * male subjects must agree to use appropriate contraception. exclusion criteria: * current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. * serum albumin level \< 3.0g/dl * pth level \> 1000pg/ml * hemoglobin level \< 8mg/dl * a history of significant gastrointestinal motility problems * biliary obstruction or proven liver dysfunction * a positive test for hepatitis b surface antigen, hepatitis c antibody or hiv 1 and 2 antibodies * a clinically significant severe lactose intolerance or sensitivity * a history of substance or alcohol abuse within the last year. * seizure disorders * a history of drug or other allergy * using cholestyramine, colestipol or colesevelam * schedule to receive a kidney transplant within the next 6 months * participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Keywords: chronic kidney disease dialysis hyperphosphatemia phosphate binder
clinical dementia rating medical record

Conditions: Clinical Dementia Rating (CDR) From the Analysis of Medical Record; Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient

Summary: the assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. however, the systematic assessment of the clinical dementia rating (cdr) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). insofar as studies have shown correspondences between the cdr and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the cdr based on information already available in the patient's file compared to the evaluation of the cdr by the usual method (face-to-face interview in consultation). this study should highlight the feasibility of scoring the cdr-sb from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.


Eligibility criteria:
inclusion criteria: * patient who has cdr assessment in face-to-face interview during the memory consultation, * patient with an isolated cognitive complaint or a neurocognitive disorder * patient included in the memora cohort exclusion criteria: * patient or caregiver who does not wish their data to be used for research purposes within the framework of the memora cohort.

Keywords: cdr memory consultation patient's file reliability
administration of surfactant through an instillation device infasurf® (calfactant) in neonates- a pilot study

Conditions: RDS of Prematurity; Surfactant Protein B Deficiency; Chronic Lung Disease

Summary: a pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with rds.

surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (rds). all commercially available surfactants for clinical use are approved for administration through an endotracheal tube. placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. the proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

Eligibility criteria:
inclusion criteria: * gestational age at the time of enrollment ≥ 24 0/7 weeks * weight at the time of enrollment 500- 5000 grams * age ≤ 24 hours old * require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation) * require fio2 ≤ 40% * clinical diagnosis of rds exclusion criteria: * prior surfactant administration * prior mechanical ventilation * major congenital anomaly * abnormality of the airway * respiratory distress secondary to an etiology other than rds (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) * apgar score \< 5 at 5 minutes of age

Keywords: neonatal rds rds surfactant deficiency
mechanisms of cell death in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy is a genetically based disease that affects motor neurons in the spinal cord and leads to muscle wasting and weakness. the gene found to be responsible for the underlying disease is called the smn or survival motor neuron gene. individuals with sma are either missing a copy of the gene or have a mutation in the gene. although the gene has been identified, how it actually causes the motor neurons to die and leads to muscle wasting and weakness is not completely understood. the investigators have found that skin cells from children with sma tend to be more susceptible to cell death when exposed to cell death inducing agents. in this protocol, the investigators wish to study the mechanisms by which these cells die when exposed to these agents and how this may be related to the gene defect and the disease.

spinal muscular atrophy (sma) is a neuromuscular disease characterized by degeneration of motor neurons and progressive muscle atrophy. the disease is one of the most common genetic causes of infant death. the gene responsible for sma, survival motor neuron (smn), exists in humans as two nearly identical copies (smn1 and smn2). only deletion or mutation(s) of the telomeric copy of the gene (smn1) causes the disease. the smn protein has been known to function in assembly of the rna splicing complex, however, the mechanism(s) by which smn-deficiency causes cell death in sma are not clear. the long-term goal is to understand the mechanism(s) of motor neuron death in sma and develop a means of prevention. smn protein has been reported to have some survival promoting functions in cultured cells. preliminary studies show that skin fibroblasts from sma patients are more sensitive to certain death promoting stimuli than control fibroblasts. the investigators hypothesize that the smn protein is directly involved in cell survival and that loss of this survival function of sma results in motor neuron death in sma. the investigators will use fibroblasts from sma patients, fibroblasts from controls without sma, motor neuron-like cell lines (such as nsc-34) and rodent primary motor neuron cultures as model systems to test our hypothesis. the investigators will determine the effect of expression of smn protein in regulating cell death of sma fibroblasts. the investigators will further investigate the role of smn in neuronal cell survival. finally, the investigators will determine biological pathway(s) of smn-mediated cell protection. results from the proposed studies will provide insight into the mechanism(s) by which smn protects cells from death and how a decrease in smn function leads to the sma phenotype. ultimately, the obtained information could lead to develop therapeutic strategies for sma.

Eligibility criteria:
inclusion criteria: * diagnosis of sma confirmed by neurologist exclusion criteria: * not seen as a patient at a participating nemours facility

Keywords: spinal muscular atrophy sma motor neuron abnormalities
use of a new stapling device in general thoracic surgery

Conditions: Thoracic Cancer

Summary: the goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

a prospective study was conducted with 80 consecutive thoracic cases. stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Eligibility criteria:
inclusion criteria: * patients undergoing planned vats or open lung resection surgery (lobectomy or wedge resection) exclusion criteria: * active bacterial or fungal infection * prior history of vats or open lung surgery * use of staple line reinforcement material (buttress) * patients under the age of 18 on the date of the surgery * any female patient who is pregnant * scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and vats lymphadenectomy are allowed)
cross sectional analysis of healthcare for psoriasis in 4 european countries

Conditions: Psoriasis

Summary: analysis of barriers in psoriasis care from the patient's and the physician's perspective and generation of scientific data on the quality of health care in denmark, poland, spain, and germany

cross-sectional, non-interventional study on healthcare for psoriasis in patients and their treating physicians. clinical data on severity as well as subjective estimates on disease burden, quality of life etc. will be collected. data collection is planned at multiple, representative sites in foureuropean countries with different healthcare systems with the aim to identify system-dependent and -independent barriers in guideline-compliant psoriasis care.

Eligibility criteria:
inclusion criteria: * clinically diagnosed psoriasis vulgaris * age ≥ 18 * written informed consent exclusion criteria: * lack of mental, physical or linguistic ability to participate in a questionnaire survey
moderate hypothermia in neonatal hypoxic ischemic encephalopathy

Conditions: Neonatal Asphyxial Encephalopathy; Hypoxic Ischemic Encephalopathy

Summary: this study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°c) vs normothermia (37°c) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

the trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by bayley ii or vineland tests between normothermic and hypothermic groups. this trial identified potential safety outcomes, compared the adverse effects of hypothermia among hypoxic-ischemic encephalopathy (hie) infants in the normothermic and hypothermic treatment groups, and obtained rates of adverse outcomes.

Eligibility criteria:
inclusion criteria: one clinical indication of hypoxic-ischemic injury * cord gas ph ≤ 7.0 or base deficit ≥13, * initial infant gas ph \< 7.1, * apgar score ≤5 at 10 minutes, * continued resuscitation after 5 min, * fetal bradycardia with heart rate \< 80 beats per minute lasting ≥15 min, * postnatal event o2 sat \<70% or arterial o2\<35 for 20 min with ischemia and two neurologic findings of neonatal encephalopathy, abnormalities of: * tone, * reflexes, * state of consciousness, * seizures, * posturing, * autonomic dysfunction exclusion criteria: * maternal chorioamnionitis, * sepsis at birth, * birth weight or head circumference \<10%, * presumed chromosomal abnormality

Keywords: hypothermia treatment